Trials / Completed
CompletedNCT03808376
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 208 (actual)
- Sponsor
- Senseonics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Continuous Glucose Monitoring System | The Eversense® 180 CGM System |
Timeline
- Start date
- 2018-12-27
- Primary completion
- 2020-05-08
- Completion
- 2020-05-08
- First posted
- 2019-01-17
- Last updated
- 2024-08-20
- Results posted
- 2024-08-20
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03808376. Inclusion in this directory is not an endorsement.